The ASM presented recommendations to the Centers for Medicare & Medicaid Services (CMS) at its annual Clinical Laboratory Fee Schedule public meeting determining payment levels for new tests for 2014.

The American Society for Microbiology (ASM) appreciates the opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS) regarding payment methodology to be used for new codes which will be included in the 2014 Medicare Clinical Laboratory Fee Schedule, as announced in the Federal Register on May 24, 2013 [CMS-1451-N]. The American Society for Microbiology, headquartered in Washington, D.C., is the largest single life science association, with over 37,000 members worldwide. Its members work in educational, research, industrial, and government settings on issues such as the environment, the prevention and treatment of infectious diseases, laboratory and diagnostic medicine, and food and water safety. The ASM’s mission is to advance the microbiological sciences as a vehicle for understanding life processes and to apply and communicate this knowledge for the improvement of health and environmental and economic well-being worldwide.

Many of ASM’s members have primary involvement in clinical laboratory medicine including individuals directing clinical microbiology, immunology and molecular diagnostic laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing products for use, and researchers involved in developing and evaluating new technologies. Therefore, the ASM has significant interest in the process of establishing reasonable reimbursement for medically necessary laboratory testing to ensure quality patient care for Medicare beneficiaries.

Below is the ASM’s recommendation with respect to payment determinations for new Current Procedural Terminology (CPT) code 876XX to be included in the 2014 Medicare Clinical Laboratory Fee Schedule. We have limited our comments to those tests that affect our constituency, and our recommendations are based on the consensus of ASM’s Public and Scientific Affairs Board Committee on Professional Affairs and Committee on Laboratory Practices, which reviewed the codes to be addressed and provided input. Our comments include the following information, as outlined in the May 24, 2013 Federal Register notice:

The purpose of this test is the detection of the sexually-transmitted protozoan parasite, Trichomonas vaginalis, in urogenital samples as an aid in the diagnosis and management of patients with signs and symptoms of infection or who are at risk for asymptomatic infection. The method uses a nucleic acid amplification methodology for the highly sensitive and specific detection of this agent. Upon detection, patients and their partners are generally prescribed an appropriate antimicrobial agent to eradicate the organism, achieve clinical resolution, and reduce risk for transmission.

Costs: Costs for this test are comparable to those for other nucleic acid amplification tests for sexually transmitted disease agents

Charges: Charges for this test are comparable to those for other nucleic acid amplification tests for sexually transmitted disease agents.

Recommendation (cross-walking or gap-fill) and data on which recommendation is based:

The ASM recommendation is to crosswalk new CPT code 876XX to existing CPT code 87481, “Infectious agent detection by nucleic acid (DNA or RNA); Candida species, amplified probe technique” with a 2013 NLA of $48.24. The rationale is that both of these codes represent tests to detect organisms associated with urogenital infections, in particular vaginitis, and may be used in concert in the diagnosis and management of patients suspected of having such an infection (1).

We greatly appreciate the opportunity to comment on fee setting for 2014 CPT codes in this public forum. If additional supporting materials are required, we will provide them on request.